NCT00264082已完成不适用
"Tartrate-Resistant Acid Phosphatase as a Bone Resorption Marker in Stage IV Breast Cancer Patients With Bone Metastasis During Zometa Treatment: A Pilot Study"
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The purpose of this research study is to evaluate the usefulness of the TRAP protein as (1) an early indicator of bone destruction and (2) a tool for assessing the effect of Zometa® in treating symptoms of bone metastases due to breast cancer. Tartrate-resistant acid phosphatase (TRAP) is a protein released into the blood stream as a result of bone destruction caused by metastasis of breast cancer to the bone. Bone destruction causes pain and bone fractures. This study will measure TRAP levels in serum taken from breast cancer patients to see if TRAP levels will be able to predict the effect of Zometa® treatment on bone destruction, pain and bone fractures.
研究设计
- 研究类型
- Observational
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic documentation of breast cancer.
- •Stage IV Breast Cancer Patients with bone metastasis for whom Zometa treatment will be initiated.
- •Written informed consent prior to study entry
- •Patients may be currently receiving hormone therapy, chemotherapy and/or radiation therapy to the primary tumor.
- •Life expectancy of at least 6 months.
- •We will include patients who have had previous or current radiation therapy to breast
排除标准
- •Concurrent malignancy with a second primary
- •Stage I, Stage II and Stage III
- •ECOG Performance Status 3 or
- •Renal Failure - serum creatinine >2.O mg/dL at screening
- •AST or ALT > ULN X
- •at screening
- •Bilirubin > 3.0 mg/dL at screening
- •Pregnant women
- •Prior or current bisphosphonate therapy
- •Any skeletal related event due to malignancy prior to study enrollment.
- •Patients with osteoporotic fractures prior to study enrollment.
- •Allergy to bisphosphonates
- •Any radiation therapy for the treatment of bone metastases <4 weeks prior to study start.
- •Any chronic medical condition which would preclude performance or adherence to protocol requirements
- •Inability to provide informed consent
研究者
研究点 (1)
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